Effects of Vitamin E Supplementation on Free Radicals and Fat Level of Obese Adolescence in Jakarta, Indonesia

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Obesity, Adolescent; Oxidative Stress

Treatments: Drug: Placebo oral capsule; Drug: Vitamin E 400 UNT

Study type: Interventional

Funder types: Other

Identifiers

NCT03358524

001

Details and patient eligibility

About

This study evaluate supplementation of vitamin E (alpha-tocopherol) in obese adolescent. Half of the patient will receive vitamin E and the other half received placebo

Full description

One of obesity treatments that play important role is antioxidant diet. The effects of vitamin E supplementation as an antioxidant treatment in obese adolescent have not been concluded yet in Indonesia. The primary aim of this study is to observe oxidative stress biomarker (isoprostane) in obese teenagers who consume vitamin E for 2 months. The secondary aim is to observe their body mass index and lipid profile after supplementation

The study is randomized, double blind, placebo controlled trial in design and employed a consecutive sampling technique to sample subjects of 70 obese adolescent age 14 - 18 in senior high schools Jakarta.

Blood tests of lipid profile (total cholesterol, HDL, LDL, Triglyceride), fasting blood glucose, liver function (AST,ALT) and oxidative stress biomarker (isoprostane) were taken for every subject after done fasting for 12 hours.

This study is a randomized allocation and double blind technique. subjects divided into two groups, which one group receiving treatment of vitamin E and other group receiving placebo.

The dose and duration of vitamin E treatment is 400 IU per day for 2 months. At the end of treatment, all subjects had to run the same medical interview, physical examination and blood test.

Enrollment: 69 patients

Sex: All

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Obesity BMI ≥ p95 (CDC growth curve)

Exclusion criteria

• Consuming antioxidants drug regularly within recruiting time
• Consuming Orlistat

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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69 participants in 2 patient groups, including a placebo group

Vitamin E 400 IU

Experimental group

Description:

Vitamin-E Capsule (alpha-tocopherol) 400 IU once per day orally for 8 weeks

Treatment:

Drug: Vitamin E 400 UNT

Placebo

Placebo Comparator group

Description:

Placebo capsule once per day orally for 8 weeks

Treatment:

Drug: Placebo oral capsule